Hyperinflammation and Hyperferritinemia in Critically Ill... | NCT06820905

Studies
Hyperinflammation and Hyperferritinemia in Critically Ill Patients

NCT06820905

Sponsor

Charles University, Czech Republic

Status

Not yet recruiting

Last Update Posted

Feb 11, 2025Actual

Enrollment

1,962Estimated

Phase

Not provided

Conditions

Critical Illness
Sepsis
Hyperferritinemia
Hyperinflammatory Syndrome

Interventions

Not provided

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2025Estimated

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Feb 6, 2025

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2025

Last Update Posted Date

Feb 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Karvunidis, Principal investigator, Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,962Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
critically ill patients		critically ill patients admitted to ICU between 01.01.2020 and 31.12.2024

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hyperferritinemia	trajectory of critically ill patients with significant hyperferritinemia and with regard to its dynamics; ferritin value cutt-off	2025

Secondary Outcomes

Measure	Description	Time Frame
etiology and association of hyperferritinemia	etiology and association of hyperferritinemia with infectioius a non-infectious diseases/conditions	2025
mortality a morbidity	mortality a morbidity of patients with significant hyperferritinemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

critically ill patients
admission between 01.01.2020 and 31.12.2024 (5yrs)

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

critically ill patients; mix-cases medical ICU population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Karvunidis, MD, PhD	Contact	+420776160620		karvunidist@fnplzen.cz

Overall Officials

Name	Affiliation	Role
Thomas Karvunidis, MD, PhD	Faculty of Medicine and Teaching Hospital, Charles University, Pilsen, Czech Republic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine and Teaching Hospital, Charles University		Pilsen	Czech Republic	30460	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D018805	Sepsis
D000085583	Hyperferritinemia

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided